EU Regulation On Identifier For Medical Products Published

By Catherine Saez

An anti-counterfeiting regulation on a unique identifier for medical products to ensure their authenticity was published today in the European Union.

The European Commission Delegated Regulation EU 2016/161 [pdf] will allow for medicinal products to be verified and individual packs to be identified, according to the European Commission. It was adopted on 2 October 2015, and will apply as of 9 February 2019.

According to EUR-Lex, which provides information on European Union law, delegated acts mean that “the EU legislator (generally, the European Parliament and the Council)” can delegate to the Commission “the power to adopt non-legislative acts of general application that supplement or amend certain non-essential elements of a legislative act.”

According to the regulation, the manufacturer “shall place on the packaging of a medicinal product a unique identifier,” which complies with a number of technical specifications, such as the batch number, the expiry date, and a code allowing the identification of at least the name, the common name, the pharmaceutical form, the strength, the pack size and the pack type of the medicinal product.

The unique identifier “shall be a sequence of numeric or alphanumeric characters that is unique to a given pack of a medicinal product,” the regulation states.

The measure is aimed at “falsified” medical products, those presented as something they are not. “Counterfeit” medical products typically refer to trademark violations.

The measure was applauded by the European Generic and Biosimilar Medicines Association (EGA) as a major step in the fight against counterfeit medicines.

The EGA said it will work to ensure the national implementation of an “interoperable, pan-European repositories system, called the European Medicines Verification blueprint System,” with other stakeholders, such as the European Federation of Pharmaceutical Industries and Associations, the European Association of Euro Pharmaceutical Companies, the European Healthcare Distribution Association, and the Pharmaceutical Group of the European Union.